ostom-i™ Alert Sensor Development

Q&A with Inventor Michael Seres

BY CAROL STOPA, VP, BUSINESS DEVELOPMENT, PHYSICIANS ENDOSCOPY

I HAD THE GOOD FORTUNE OF MEETING MICHAEL SERES AT THIS YEAR'S GI ROUNDTABLE IN BOSTON. MICHAEL IS THE INVENTOR OF THE OSTOM-I ALERT SENSOR, AN INNOVATIVE NEW DEVICE FOR OSTOMY PATIENTS. A FEW MONTHS LATER, HE WAS KIND ENOUGH TO SET ASIDE SOME TIME TO SHARE THE STORY BEHIND THE OSTOM-I, WHICH IS AS MUCH ABOUT THE DEVICE AS IT IS ABOUT ONE PERSON'S DESIRE TO IMPROVE HIS QUALITY OF LIFE AND THE QUALITY OF LIFE FOR PATIENTS WORLDWIDE.

Carol Stopa (CS): It's great to have the opportunity to speak with you again. Could you begin by explaining what exactly is the ostom-i device?

Michael Seres (MS): The ostom-i primarily does two things centered on improving the quality of life for ostomy patients. It is a device that, in very simple terms, clips to the outside of a patient's ostomy pouch and uses Bluetooth technology to send a signal to an app on an Android or Apple smartphone that alerts the patient through an alarm-type system that the pouch is filling up.

So at nighttime, you can put your smartphone by the bed. The sensor recalibrates depending on what position you're in so it won't give you a false reading. If an alarm goes off, you can get out of bed, empty your pouch and there won't be any accidents. If you're going out, you keep your smartphone in your pocket. You receive an alarm on your smartphone that tells you when the pouch is a certain percentage full. You can then decide whether to wait for it to fill more or empty it. The sensor is designed to essentially enable you to conduct as normal of a life as you possibly can as an ostomy patient and help avoid the leaks and spills associated with ostomy pouches. That is the primary focus of the device from a patient's perspective.

From a clinical perspective, what the ostom-i does is every time there is a change of movement in the pouch caused by output, it plots the change of movement and converts that into volume. It plots that volume over a time and allows clinicians to remotely monitor volume output. The data is automatically captured and stored in the cloud, enabling physicians to have secure, re- mote access. Alternatively, the patient can choose to have that output data automatically sent via email to the clinician's email. Therefore, it doesn't require the clinician to have any technology on their end. This automates the process and eliminates the need for patients to empty their pouch into a jug, measure the output, enter the data into a spreadsheet and phone it in to their provider. When patients use the ostom-i, it can help clinicians predict when a patient is going to suffer from dehydration or blockage — the things that lead to readmissions or ongoing treatment that the vast majority of ostomy patients take for granted.

You essentially must have a smartphone with the free ostom-i Android or iPhone app on it to use the device. The only time you wouldn't need a smartphone is if you are in a hospital or other healthcare setting. The ostom-i can be connected via Bluetooth to a tablet that would sit at a nurse's station.

CS: What motivated you to invent the ostom-i and found your company, 11 Health?

MS: I had Crohn's disease from the age of 12. I required multiple surgeries, which left me with no more than 40 cm of small bowel. This eventually resulted in intestinal failure. In October 2011, I became the 11th person to undergo a small bowel transplant in the U.K.

Part of that transplant required my having an ostomy. Learning to cope as an ostomy patient was difficult and challenging. I love gadgets, so I just assumed I would go online and buy a device that would help me. But it didn't exist. I reached out to thousands of other patients throughout the world primarily through social media to ask them how they managed being an ostomy patient. They essentially said they do what I was doing: just cope.

The transplant required me to spend seven months in the hospital, so I had a lot of time doing nothing. I bought a few tools off of eBay, watched some YouTube videos and built a very crude, very basic sensor. That was 2012, and that was the start of 11 Health. In the beginning, I would affix this sensor to my pouch and then walk around the hospital and at home to see if it would effectively send the signal as I moved around, and it did. I was then fortunate enough to be introduced to Adam Bloom, an entrepreneur and pharmacist by training, who was willing to provide me with some money to see if I could take this crude, hand-built prototype and turn it into a device.

At that point, I went from being a patient in a bed and a desk in the front room of my home, to starting a business. Since I was the 11th small bowel transplant patient in the U.K., 11 Health became the name of the company.

CS: With the business formed, what happened next?

MS: We gained momentum when we had a bit of money and were able to engage some experts who could help take this vision to the next level. We launched our first cobbled-together device on the backend of 2013. We recognized that the biggest barrier to entry was regulatory, so rather than try to just sell the ostom-i, we worked to crack the regulatory side. We did nothing with the device for nine months while we went through FDA approval and European regulatory approval.

We received full FDA 510(k) clearance in October 2014. We then spent quite a bit of time working with Medicare and other payers on getting insurance coverage. We secured reimbursement around January of this year, so that's when we really launched the device and took on some proper investments in the company.

CS: Is the ostom-i available for purchase now?

MS: You can buy it now on the 11 Health website and we will fulfill it. Our backend fulfillment is essentially done through Amazon. You buy it online and get a delivery as if you are ordering through Amazon. It is available in the U.S. and the U.K.

We also have some physicians and hospitals going through the procurement process. They will buy it and provide it to patients. We have other hospitals advising their patients who are coming in for surgery to buy it and bring it with them.

Each device lasts about 3-4 months based on average use, and then patients would be expected to purchase another one. Since it is constantly sweeping for Bluetooth, it has a limited battery life, and at the moment you can't change the battery as the ostom-i is a sealed unit. If a patient decided not to use the ostom-i around the clock, perhaps be- cause they decided only to use it when they went out, it will inevitably extend the battery life. You pair it and unpair it as you do any Bluetooth device.

The sensor's algorithm is based on about 85-90% of ostomy pouches on the market, so it's accurate within 7-8%. As we go through different versions of the device, I suspect we will be able to improve the functionality and battery life.

CS: What sort of response have you received from clinicians and patients?

MS: We have had a wonderful response thus far. The patients say, "We love it, does our clinician know about it?" The clinicians say, "We understand what this does, now we need to tell our patients about it."

Patients want a bit of validation from their clinicians, which is why we are spending more time at the moment clinician- and nurse-focused than patient-focused, but we have just appointed our first patient advocate because our intention is to also build a program around patients.

We have essentially secured a number of beta testing, user trials and clinical trials with major healthcare centers, including a clinical trial at Massachusetts General Hospital, beta testing with Mayo Clinic, patient testing with Stanford, and we are doing some work with Kaiser and Cedars Sinai. Everyone has a slightly different twist on why they want the device, and we are working to accommodate their needs. We took a view that if we were privileged enough to have these major organizations wanting to engage with us, we would go through the early adopter testing phase, prove the efficacy and then start rolling out sales. We just hired a vice president of sales and we are about to open a very small office in Palo Alto, CA. We're in a situation now where we need to get the word out to more people.

We're still in the early stages, but I feel we are going in the right direction.

CS: Many believe that out of personal struggles and difficulties comes greatness and strength. You have been able to turn your challenging life experience into something extremely positive, not only for yourself but hundreds of thousands of patients everywhere.

MS: This has quickly gone from being me on my own, then I had a company and now it's a company with some share- holders. We're not a big entity, but we're growing. But what is most important to me is I want to make sure we remain focused on how this device serves to help the lives of patients. If we do that well, the company will be successful.

CS: What does the future hold for 11 Health?

MS: We have a next generation version of the device and some app-related projects under development, which will probably come together in 2016. But we know we have to get the ostom-i right first before we launch anything else.

Besides that, my real passion is promoting the role patients can play in health- care. This work is my life — this is all I do. I really believe there are many patients who are like me and working to solve the problems they face every single day. I'm lucky that my solution was able to gain a bit of traction, and through some generous investments I have been able to carry it forward.

Hopefully through the success we have had and hopefully will continue to have going forward, that will encourage others to pursue their visions and work to make a difference in the lives of other patients. That's what I really care most about.

Carol Stopa is a vice president of business development at Physicians Endoscopy. Carol is responsible for developing new market initiatives as well as identifying and generating qualified business opportunities within the physician community in regards to new partnerships, acquisitions and hospital/health system joint ventures. She is also the editor- in-chief for EndoEconomics. Prior to joining the PE team, Ms. Stopa worked in clinical and administrative healthcare including mental health centers, correctional facilities, and psychiatric healthcare management companies. She may be reached at cstopa@endocenters.com.